QC Micro Analyst role involves performing microbiology, chemistry, and biochemistry testing to support manufacturing operations.
This position requires a degree in a science discipline and a minimum of 2 years experience in the Pharmaceutical Industry.
Job Description
Perform a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
- Rapid turnaround of samples to meet manufacturing needs.
- Perform data review and approval.
- Provide support and advice to manufacturing on QC related topics.
- Initiate and lead investigations where required.
- Initiate and complete CAPAs and Change Controls in accordance with site procedure.
- Write new and update current procedures on electronic documentation system.
- Provide training to other analysts and to manufacturing personnel.
- Present technical analytical data clearly and concisely to customers.
- Proactively identify and implement lab process improvements.
- Support lean initiatives in the area of lab operations.
- Support Team leader on day to day testing operations.
Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
Experience with Bioburden, Endotoxin, Sterility Testing, Microbial Identification using genetic methods.